federal_register: 94-2265

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
94-2265 Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Amendment to Tentative Final Monograph; Proposed Rule Uncategorized Document The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking amending the tentative final monograph for over- the-counter (OTC) internal analgesic, antipyretic, and antirheumatic drug products. This proposal affects combinations of internal analgesic and antacid ingredients, specifically sodium bicarbonate used as an antacid active ingredient. As proposed, combination drug products intended to be dissolved in liquid prior to administration, such as powders and effervescent granules or tablets, would not be allowed to make a claim for ``relief of overindulgence in food and drink'' or a claim for ``relief of hangover.'' FDA is issuing this notice of proposed rulemaking after receiving reports of gastric (stomach) rupture following ingestion of sodium bicarbonate to relieve gastrointestinal distress. This proposal is part of the ongoing review of OTC drug products conducted by FDA. 1994-02-02 1994 2 https://www.federalregister.gov/documents/1994/02/02/94-2265/internal-analgesic-antipyretic-and-antirheumatic-drug-products-for-over-the-counter-human-use       The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking amending the tentative final monograph for over- the-counter (OTC) internal analgesic, antipyretic, and antirheumatic drug products. This proposal affects combinations of...

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